ORLANDO, Fla. — Patients with type 1 and 2 diabetes who delay treatment with recommended statin therapy to address the well-known high risk for cardiovascular (CV) events show significantly higher rates of CV events over a 10-year follow-up compared with those treated without delay.
“We found that delays in statin therapy — even by just a few years — could have a significant risk for patients in terms of having poor health outcomes and adverse cardiovascular events,” said lead author Nisarg Shah, a medical student with the Yale School of Medicine, New Haven, Connecticut, in presenting the findings at the American Diabetes Association’s 84th Scientific Sessions.
“We hope these findings can help guide clinicians [in general] to improve cardiovascular health in this high-risk population, understanding that non-acceptance initially can have a very significant risk and impact for patients overall,” he said.
In the study of 7239 patients with type 2 diabetes, 17.7% of patients delayed their recommended statin therapy, for a mean of 2.7 years.
Over a follow-up of 10 years, those who accepted the recommended statin therapy from the start had a 6.4% risk of having an adverse CV event, while the rate was significantly higher, 8.5%, among those who had delayed statin therapy (P=.001).
“Those who delayed statin use had a 30% increased risk of experiencing a cardiovascular event at 10 years,” Shah said.
Statins Recommended to Prevent Diabetes’ CV Risk
Diabetes is well-established as a risk factor for atherosclerotic cardiovascular disease (ASCVD) and is a leading cause of death for people with diabetes, Shah noted.
To address the risk, ADA guidelines recommend statin therapy for patients 40-75 years of age, even if they don’t have other cardiovascular risk factors, and for patients younger and older, in varying dose intensities based on their risk factors.
However, common reasons for not accepting the treatment include non-acceptance of the therapy, concerns over side effects, clinical inertia on behalf of the prescribing physician, and other factors, Shah said.
He noted a study of adults with diabetes, conducted between 2015 and 2018, showed that only 53% of patients were prescribed statins, despite the fact that most met the clinical indications for the treatment.
“This indicates that there is a large proportion of the population not being prescribed this important therapy,” Shah said.
With research lacking on the long-term implications of failing to accept statin therapy, Shah and his colleagues conducted the retrospective observational study of patients with a diagnosis of type 1 or 2 diabetes without ASCVD treated at Mass General Brigham in Boston between 2000 and 2018.
The patients had a mean age of 55 years and 52.1% were female. They had an elevated mean baseline LDL-cholesterol level of 138 mg/dL and their mean A1c was 7.5%. Consistent with the general population, the majority had type 2 diabetes.
The acceptance of statins was determined using a natural-language processing algorithm to assess physician notes in medical records.
Among the 17.7% of patients who delayed receiving statin therapy, patients had a mean of 4.6 healthcare provider visits between the time of initial non-acceptance to initiation of the therapy.
Once beginning the delayed statin therapy, the patients remained on the treatment for a mean of 7.1 (standard deviation [SD] 4.8) years.
With a mean follow-up time of 8.2 years, 455 (6.3%) patients overall experienced an adverse CV event.
In terms of specific events among the 8.5% who experienced CV events after delayed statins over the 10-year follow-up, rates were significantly higher for myocardial infarction as well as ischemic stroke vs those who didn’t have delays in statin therapy (both P=.001).
A multivariate analysis adjusting for factors including patients’ demographic characteristics and comorbidities, and clustering within healthcare providers, showed that the initial non-acceptance of statin therapy was the strongest factor, associated with a 49% increased risk for a CV event (hazard ratio, 1.49; P=.002).
A further assessment of LDL based on statin acceptance indicated significantly higher mean LDL status over the course of 12 years, at every time point, among those who delayed acceptance of statins (P <.001>
The increased rate of CVD events “is a lot, especially as it’s the most common cause of death in patients with diabetes to begin with,” the study’s senior author, Alexander Turchin, MD, director of informatics research at Brigham and Women’s Hospital, told Medscape Medical News.
“Given that nearly 20% of patients with diabetes did not accept statin therapy recommendations by their clinicians, it becomes an important public health issue,” he said.
In his talk, Shah speculated that specific reasons for delaying statin treatment can include concerns about common reports of side effects such as muscle pain with the drugs, in addition to a lack of symptoms of high cholesterol before a serious CV event such as stroke occurs.
Encouraging Patients: “A Dance Led by the Clinician”
Commenting on the issue, session moderator Mohammed K. Ali, MD, of Emory University in Atlanta, Georgia, told Medscape Medical News that the high ranking of statin delays in terms of CV risk was, regrettably, “not a surprise.”
“I have two broad reasons for this — [one is that] statins are extremely effective, and we have about 50 years of data showing they lower cardiovascular events by 30% to 40%,” he said.
“The other reason is that statin hesitancy and/or non-adherence are very common and fueled by a combination of distrust in allopathic medicine and misinformation.”
Encouraging patients and explaining the benefits of statins in diabetes can involve some careful maneuvering, he added.
“I think counseling and patient-centered decision-making is like a dance led by the clinician,” Ali explained. “A deft clinician will offer data as the conversation with the patient evolves. In the circumstance of sensing hesitancy, these data points, especially if conveyed clearly — such as [the current] study, showing that avoiding statins was associated with a 50% higher risk of heart attacks and stroke — may be important in persuading the patient to take the statin.”
Turchin added his take on strategies for improving early patient uptake: “Based on our clinical experience, having multiple conversations with the patient over time, providing detailed information on the pros and cons of statin therapy, and involving their family members in the decision-making process can be helpful,” he said.
Overall, however, the findings underscore that “non-acceptance of statin therapy by patients with diabetes is a common occurrence that could have a major impact on their health,” Turchin said.
“Clinicians should do everything possible to help these high-risk individuals make fully informed decisions about their treatment options.”
Turchin disclosed relationships with Eli Lilly, Novo Nordisk, Proteomics International, and AstraZeneca. Shah and Ali reported no relevant financial relationships.
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